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Medical Device Risk Management

A course presented over 2 half-days, 6 half-day or 3 full-day by Bijan Elahi

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Summary
Course Overview
Course Outline
Video

Medical Devices Risk Management (MDRM) is a progressively more prominent topic in the medical device industry. Expectations by Regulatory bodies of medical device companies in producing quality, logical and defensible risk management files is rising. It is incumbent on the medical device manufacturers to convince the regulatory bodies that the benefits of a medical device outweigh its risks.

This course teaches a disciplined systematic approach to the analysis, estimation, evaluation, and control of safety risks associated with medical devices. This method is explainable, logical and integrated. Application of formal risk management techniques can help predict and prevent serious harm to patients and losses to businesses.

This training course provides a comprehensive introduction to topics that are needed for successful management of safety risks of medical devices in conformance with the international standard ISO 14971. The scope of risk management includes both pre-market product development, and post-market risk management.

This course may be credited toward the maintenance of the Project Management Institute (PMI) certifications. Suggested PMI Talent Triangle® PDU allocation:

Medical Device Risk Management 3-Day
- Ways of Working - 20
- Business Acumen - 1

Medical Device Risk Management 4 Half-Day
- Ways of Working - 13
- Business Acumen - 1

Medical Device Risk Management 2 Half-Day
- Ways of Working - 6
- Business Acumen - 1

The course commences with the fundamentals of medical devices risk management, then builds upon the fundamentals, and teaches a practical, sensible and efficient way of performing medical devices risk management. The course includes multiple quizzes to deepen the learning, and create an engaging learning experience.

Topics such as medical device software risk management, cybersecurity are also addressed in this course.

This course will benefit:

Practitioners of medical devices risk management– including product risk managers, systems engineers, design engineers, manufacturing engineers, quality engineers, usability engineers.
Evaluators of medical devices risk management– including quality assurance, management, regulatory staff.
People with a need for a general understanding of medical devices risk management– including clinical, marketing, packaging, toxicology, management.

Participants will not need prior knowledge or experience with medical device risk management, but experience in medical device development would be an advantage.

Course Method and Materials:

Participants are provided with a copy of the presentation materials and reference resources.

The companion textbook, “Safety Risk Management for Medical Devices” authored by the course facilitator is recommended for course participants. The book provides a substantial amount of additional materials, details, and step-by-step instructions on how to perform many of the presented risk management techniques. The book may be purchased from all major booksellers, e.g., Amazon, or directly from the publisher.

Please note: it is the course participant's responsibility to purchase the book prior to course participation.

“The text, Safety Risk Management for Medical Devices, is an excellent companion for the medical device developers and entrepreneurs. As part of our lean start-up strategy we wanted to complete as much of the development in-house as possible. Elahi’s methods and resources enabled first-timers, such as ourselves, to implement a robust evidence-based risk management approach that supported the successful CE mark of our device.”

- Devakar Epari, Associate Professor in Biomedical Engineering (QUT), Co-inventor and developer of the Biphasic Plate

Some Key Questions addressed in the course:

What is the difference between cause, hazard, hazardous situation and harm?
How can we establish that risks of a medical device are reduced to as low as possible?
How can we show that the benefits of a medical device outweigh its risks?
How do we manage software risks?
How does risk management inform and influence biological evaluation of medical devices?
What is the connection between usability engineering and safety risk management?
How should we monitor production and post-production medical device information?
How should knowledge gained from production and post-production be rolled back into the medical devices risk management process?
How should medical devices risk management influence verification testing?
What is the difference between risk control and mitigation?
How do we determine when to stop reducing risks?
What factors contribute to successful analysis of hazards?

Training Objectives:

At the conclusion of this course, participants are expected to have developed a sound working knowledge of medical devices risk management in compliance with ISO 14971.

Who Should Attend this Course:

This Risk Management for Medical Devices course is designed for professionals who are engaged in medical devices development and risk management, or who need to quickly come up to speed on the theory and methods of medical device risk management, and be able to produce the required documentation to support successful submission and approval of medical devices by Regulatory Agencies.

The course will also be of value to those who will not perform medical devices risk management but are required to review and approve medical devices risk management artifacts.

Course Availability:

This course is offered online at the scheduled dates. It is also available for on-site delivery at client-provided facilities. The on-site course can be augmented with hands-on workshops to practice the techniques of risk management.

Do you Offer Tailoring of this Course?

Yes. All courses are tailored informally verbally in delivery by selecting, where possible, examples matched to the domains of interest to the class. We can also work with you to design a formally customized curriculum for the development of your people. We have done so for many client companies, and we would love to work with you to this end. We always suggest that a client takes the corresponding standard course prior to any customization. For systems engineering, this is because systems engineering is the problem-independent and solution technology-independent principles and supporting methods for the engineering of systems, based on systems thinking. So the objectives of customization need to be very clear and focused on adding further value. In practice, customization, if performed, usually becomes the replacement of examples and possibly the main workshop system with domain-specific equivalents. Substitution of the workshop system usually involves substantial redevelopment of courseware. Out of necessity, formal tailoring of courseware is performed on a fee basis.

1. The Value Proposition for World Class Medical Device Risk Management

Proper risk management is a value-adding activity to medical device product development. Efficient, intelligent, and effective risk management ensures smooth product approvals, reduced field corrective actions, and achieves significant cost savings to the business.

2. Introduction to Medical Device Risk Management

Why do we need to do medical device risk management?
The benefits of medical device risk management
Safety as an emergent system property
History and origins of risk management
Safety constraints
Cybersecurity and safety risk management
Language of risk management
Hazard theory
Hazard Taxonomy
How to distinguish subtle concepts in risk management
Quiz

3. Medical Device Risk Management Standards

ISO 14971 – the central standard in medical device risk management
Requirements of ISO 14971
Other related safety standards: IEC 60601-1, IEC 62366, IEC 62304, ISO 10993

4. Medical Device Risk Management as a Value-Added Activity

Risk management contribution to the various lifecycles in product development

5. Medical Device Risk Management Activities and Artifacts

Risk management plan
Risk management report
RM file
RM process
Risk analysis

6. Foundations for Medical Device Risk Management

System types
Clinical Hazards List (CHL)
What it is
How to create it
Risk estimation
Classic and advanced methods
Harms Assessment List (HAL)
What it is
How to create it
Quiz

7. Medical Device Risk Management Tools and techniques

Fault Tree Analysis (FTA)
Preliminary Hazard Analysis
Failure Modes and Effects Analysis (FMEA/FMECA)
Is FMEA risk management?
Relationship between FMEA and FTA
Domains of Severity, Occurrence and Detectability
Risk management scaling via hierarchical-multi-level FMEA
FMEA cascade
Usability Engineering and risk management
How to distinguish reasonably foreseeable misuse

8. Software Medical Device Risk Management

Introduction
Software failure model
Language of SW risk management
Contribution of software to system hazards
Software risk

9. Medical Device Risk Assessment

Risk Assessment and Control Table (RACT)
Risk integration
RACT workflow
P1 and P2
Risk controls
Safe by design
Protective Measures
Information for safety
Risk controls end-point logic
Verification of risk controls
Residual risk
Traceability

10. Benefit-Risk Analysis

FDA guidance
Criteria for benefit-risk analysis
FDA decision-making factors

11. Post-market Medical Device Risk Management

Listening systems
Surveillance
Complaint handling

12. In Closing

Common mistakes in medical device risk management
Tips and wisdom for success.

Best Practices in Risk Management

PPI Course Presenter and Principal Consultant Bijan Elahi, an expert on a world scale in medical device risk management, shares his wisdom in medical device risk management in this interview.

Bijan Elahi is also the author and presenter of PPI’s Medical Device Risk Management training course.